Effect of Miralax NPO Time on Residual Gastric Volumes and Bowel Preparation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorStanford University

About this trial

The goal of this clinical trial is to assess differences in residual gastric volumes after stopping Miralax ingestion at different time points (2, 4, 6 hours) prior to anesthesia induction and compare it to the control (current institutional standard of care where no Miralax is given on the day of surgery).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing both EGD and colonoscopy

Use of Miralax for cleanout

Patients <19 years old

Disqualifiers

Patients with a history of delayed gastric emptying (eg diabetic, GLP-1 intake)

Patients with a history of gastric sleeve surgery

Use of Golytely for cleanout

Emergent EGD/colonoscopies

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stopping Miralax ingestion 4 hours prior to anesthesia induction

    Behavioral

    Stopping Miralax ingestion 4 hours prior to anesthesia induction

  • Stopping Miralax ingestion 6 hours prior to anesthesia induction

    Behavioral

    Stopping Miralax ingestion 6 hours prior to anesthesia induction

  • Stopping Miralax ingestion 2 hours prior to anesthesia induction

    Behavioral

    Stopping Miralax ingestion 2 hours prior to anesthesia induction

  • Control

    Behavioral

    Miralax will not be given on the day of surgery

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: 4hr NPOActive comparator 1 intervention
Group B: 6hr NPOActive comparator 1 intervention
Group C: 2hr NPOActive comparator 1 intervention
Group D: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Residual gastric volume as measured by EGD

Time frame
To be performed at the start of the EGD immediately after anesthesia induction.

Secondary outcomes

1

Preoperative gastric POCUS volume assessment

Time frame
Performed prior to anesthesia induction
2

Effectiveness of colonoscopy cleanout

The effectiveness of colonoscopy cleanout will be assessed by the Boston Bowel Preparation Scale (BBPS).

Time frame
Performed during the colonoscopy portion following upper GI endoscopy (EGD)
3

Incidence of aspiration on induction and perioperative aspiration

Time frame
On anesthesia induction

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: